The present invention relates to percutaneous vaccine applicator systems and more specifically a percutaneous vaccine applicator system which minimizes the risk of cross contamination by way of the applicator between the person administering the vaccine and the recipient of the vaccine.
A variety of vaccines are administered by percutaneous inoculation. A percutaneous inoculation requires piercing the surface of a patient's skin to deliver the vaccine immediately under the surface of the skin. For example, prior art procedures start by swabbing or wiping a dose of vaccine over a selected area of a patient's skin. Often the vaccine is swabbed on a small area of the patient's arm approximating the size and shape of the vaccine applicator. The vaccine applicator includes a plurality of spikes which are used to puncture a patient's skin and drive the vaccine underneath the skin. The applicator is positioned over the vaccine swabbed area and a force is applied to the applicator so that the spikes penetrate the skin surface. A portion of vaccine is delivered below the skin surface by the action of the spikes penetrating the skin. The applicator is lifted from the patient's skin and the vaccine in the swabbed area is wiped into the punctures created by the spikes to assure maximum delivery of vaccine.
Such a vaccine delivery system is utilized to inoculate people with tuberculosis vaccine. Without going into detail regarding tuberculosis or specific vaccines, it is preferable to deliver certain types of tuberculosis vaccine percutaneously. Other vaccines may also be delivered in this manner.
Tuberculosis infections have been increasing throughout the world and as such it is extremely important to increase vaccination efforts to prevent or minimize the spread of tuberculosis. While tuberculosis is a highly communicable disease which primarily affects the lung and may be terminal, vaccination against tuberculosis is highly effective.
As will be discussed hereinbelow, prior art percutaneous vaccination applicator systems are difficult to use, create blood contamination hazards for technicians, patients and waste handlers, and disposal problems. As such it would be highly desirable to provide a percutaneous vaccine applicator system which overcomes the prior art problems.
Prior art applicator systems create many problems in the percutaneous application of vaccines. The prior system includes a very thin, wafer-like stainless steel plate with numerous spikes protruding from one of the surfaces. The thin wafer-like plate can be very small measuring 7/8 inches by 11/8 inches. This wafer-like plate is provided in sterilized flexible material pouch which is subject to being punctured by the spikes on the plate.
The packaging for the spiked plates provides a potential for contamination. First, the plate may be contaminated by puncturing the pouch thereby breaching the sterility of the pouch. Secondly, if the pouch is pierced, a person handling the pouch may contaminate the tips of the spikes if they are punctured or if they in any way handle the plate. Additionally, the tips of the spikes may become dulled by piercing the pouch material or bumping against other surfaces after having pierced the pouch material. Dulled spiked surfaces make administration of the vaccine more difficult and more painful for the patient.
Employing the vaccination procedures described hereinabove, a plate is removed from a pouch and picked up using a magnetic handle. The magnetic handle is used to position the plate over a vaccine swabbed area on a patient's arm and drive the spikes through the vaccine and into the patient's arm. Once the spikes are buried in the skin, the handle is rocked forward and backward several times to assure that each spike has punctured the skin surface.
Next, the magnetic handle is slid to one side to disengage the handle from the plate. In a successful procedure, the spikes remain buried in the skin after the magnetic handle is removed from the plate. This step of the operation provides yet more opportunities for contamination. First, while the spiked plate is a disposable component of the vaccination system, the handle is intended to be reused. Since the handle may directly contact the vaccine and/or body fluids such as blood which may well up into the punctures created by the spikes, it is almost certain that the handle will become contaminated. Further, because the handle is a reusable item, there is the possibility that the handle may not be completely or properly sterilized and thus may contaminate other technicians or patients.
This step introduces further discomfort for the patient since the embedded spike are twisted while the handle is removed. The plate then must be lifted from the patient's arm for use in wiping the vaccine into the punctures created by the spikes. In order to lift the plate from the patient's arm one end is usually depressed into the flesh to get the opposite end to lift from the arm; causing further patient discomfort.
Proceeding with the prior art vaccination system operation, the plate is removed by the operator and one edge of the plate is used to spread vaccine into the puncture sites. Herein lies yet additional possibilities for contamination of the technician and patient. The technician may be contaminated by handling the spiked plate while removing the plate from the patient's arm and while wiping vaccine into the punctures. If a spike pierces the technician, the technician may become infected by any diseases carried by the patient. Further, after the technician is punctured, the technician may infect the patient with any diseases he may be carrying. It is apparent that the prior art provides numerous opportunities for cross contamination between technician and patient.
As an additional matter, the plates must be disposed of after completing the vaccination procedure. The packaging for the plates is a flexible material pouch. Since the pouch presents the risk of contamination before use, the pouch also presents the risk of contamination by a used spike plate. This risk of contamination goes beyond the technician and patient such that any other individual handling the very sharp multi-spiked vaccine and fluid coated medical waste, such as waste handlers, risks contamination.
While the risk of contamination by minor diseases and tuberculosis is highly undesirable, this risk is additionally alarming due to the current spread of AIDS. In view of the spread of AIDS, most medical facilities are taking additional measures to prevent cross contamination of bodily fluids. As such, it would be highly desirable to overcome the problems with the prior art discussed hereinabove.